Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors

NCT06926751 · tracked via the Priya Life Science China tracker

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Phase 2

Started

2025-06-12

Last updated

2026-05-07

Condition(s) studied

Solid TumorsChildrenAdolescentChemotherapy Induced Neutropenia

Investigational drug(s) / intervention(s)

Telpegfilgrastim Injection →filgrastim →

Telpegfilgrastim Injection: subcutaneous injections of Telpegfilgrastim (33 μg/kg, single dose) 24 hours after each chemotherapy cycle

filgrastim: subcutaneous injections of Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle

Study summary

The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are:

* Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim?
* How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety.

Participants will:

* Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle.
* Undergo blood tests, physical exams, and temperature monitoring during follow-up visits.
* Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker).
* Complete two chemotherapy cycles with close safety and efficacy monitoring.

Eligibility

Sex

ALL

Min age

6 Years

Max age

24 Years

Healthy volunteers

Inclusion Criteria: 1. Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy, with ≥2 remaining chemotherapy cycles, and either: * Previous febrile neutropenia(FN) or dose-limiting neutropenia in the prior chemotherapy cycle without prophylactic granulocyte colony-stimulating factor (G-CSF); * Previous FN or dose-limiting neutropenia in the prior chemotherapy cycle despite prophylactic G-CSF. 2. Age ≥6 to ≤24 years. 3. Eastern Cooperative Oncology Group Performance Status ≤1. 4. Normal bone marrow hematopoietic function: hemoglobin ≥75 g/L, white blood cell count ≥3.0×10\^9/L, platelets ≥80×10\^9/L, and neutrophils ≥1.5×10\^9/L. 5. Anticipated survival ≥8 months. 6. Willing to participate, with written informed consent signed by the patient or legal guardian. Exclusion Criteria: 1. Bone marrow involvement at screening. 2. Uncontrolled localized or systemic infection. 3. Known hypersensitivity to Telpegfilgrastim, recombinant human granulocyte-colony stimulating factor(rhG-CSF), or other pegylated recombinant human granulocyte colony stimulating factor(PEG-rhG-CSF) agents. 4. Concurrent participation in any other investigational drug or device trial. 5. Severe organ dysfunction: total bilirubin, alanine aminotransferase(ALT), or aspartate transaminase(AST) \>2.5 × upper limit of normal(ULN) (or \>5 × ULN in patients with liver metastases), serum creatinine \>5 × ULN. 6. Severe psychiatric disorders affecting informed consent provision or adverse event assessment. 7. Any condition deemed by the investigator to compromise patient safety or interfere with study outcomes, including risks from the investigational product or confounding adverse event evaluation.

Primary outcome measure(s)

Incidence of febrile neutropenia in Cycle 1 — 21-28 days
Incidence of febrile neutropenia in Cycle 1 (i.e., the first chemotherapy cycle post-enrollment)

Trial sites (1)

Facility	City	Region	Status
Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	China	Recruiting

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis Recruiting

Clinical Trial of BT02 in Patients With Advanced Solid Tumors Recruiting

Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer Starting soon

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients Recruiting

Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor Recruiting

Other trials for the same condition

Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors Active, not recruiting

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients Recruiting

Ningbo Maternity-Child Linked Database Study Active, not recruiting

Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS) Recruiting

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06926751 on ClinicalTrials.gov ↗ ← All trials in China